An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs
pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who
complete 4 such injections and respond well to their treatment may continue to receive an
injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms,
treatment will last until either the patient or the doctor decides that there is no clear
benefit in continuing with the treatment.
TS levels will be measured from the tumour sample used to make the original diagnosis of
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.
Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)
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United Kingdom: Medicines and Healthcare Products Regulatory Agency